NAD Recommends Nexus Formulas Discontinue Certain Challenged Claims for Plavinol, Following Challenge by the Council for Responsible Nutrition

New York, NY – November 26, 2019 – The National Advertising Division recommended that Nexus Formulas, LLC discontinue certain challenged product performance, ingredient, and safety claims, as well as doctor recommended claims and testimonials for its Plavinol dietary supplement, following a challenge by the Council for Responsible Nutrition (“CRN”).

NAD is an investigative unit of the advertising industry’s system of self-regulation and is a division of the BBB NP’s self-regulatory and dispute resolution programs.

The express claims challenged by CRN appeared in internet advertising.  NAD noted that the challenged advertising claims refer to the benefits of Plavinol and its “active ingredient” on metabolic syndrome, as well as its conditions, which include increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels.  The challenged claims promise consumers who are suffering from metabolic syndrome, or the associated conditions, that Plavinol confers significant and meaningful reductions in their symptoms and improved health – e.g., lower cholesterol, lower blood pressure, weight loss – with no side effects, in a short period of time (e.g., lowering of blood pressure in 30 days). The challenged advertising also touts that doctors recommend Plavinol to patients who suffer from metabolic syndrome.

With regard to the advertiser’s product performance claims, NAD noted that health-related product performance claims must be supported by competent and reliable scientific evidence on the actual product as it is marketed to consumers.  Although the advertiser submitted as evidence a “White Paper” that refers to the Plavinol product as a whole (as opposed to the individual ingredients in Plavinol), NAD could not conclude that it was sufficiently reliable to support any product performance claims because it was unclear who authored it.  In the absence of any product testing to support the challenged product performance claims, NAD recommended that the advertiser discontinue claims that the product itself has the claimed benefits including (1) “clinical studies in the U.S. have shown it blocks sugar in the foods you eat from entering your blood,” (2) “the clinical trials in support of the pill show it cause weight loss over a 90-day period,” (3) “[Plavinol] triggers weight loss and lowers cholesterol, triglyceride and blood pressure levels” and (4) “ . . . Plavinol . . . lowers blood sugar, triggers weight loss, and restores cholesterol, blood pressure, and triglycerides levels to normal without side effects.”

CRN also challenged several claims referring to the “active ingredient[s]” in Plavinol, including, for example, the claims that “Plavinol’s active ingredient is shown to reduce excess sugar in the blood which is why so many users are seeing a reduction in the symptoms of Metabolic Syndrome” and “this pill contains an active ingredient that also triggers weight loss and lowers high blood pressure, cholesterol and triglyceride levels.”  NAD determined that Plavinol’s references to an “active ingredient” made in conjunction with diseases such a metabolic syndrome, high lipid levels and blood pressure, and excess blood glucose reasonably convey a message that Plavinol has “active ingredients” like those demonstrated to be effective in a prescription drug.  NAD concluded that such a message is not supported by any evidence in the record, and recommended that claims referring to Plavinol containing an “active ingredient” be discontinued.

Further, NAD determined that the studies submitted by the advertiser on Plavinol’s ingredients, berberine and morus alba (or mulberry leaf extract), were not sufficiently reliable to support the challenged claims and recommended that they be discontinued, including claims that Plavinol or the berberine or morus alba in Plavinol will confer the following health benefits:

• “This pill contains an active ingredient that also triggers weight loss and lowers high blood pressure, cholesterol and triglyceride levels.”
• “[clinical study] [r]esults show those who take Plavinol’s active ingredient . . .
  • Reduce after-meal glucose spikes
  • Lower high blood pressure levels
  • Relieve high cholesterol levels
  • Cut triglyceride levels
  • Lose excess fat.”
• “ . . . [O]ne study showed that even after patients consumed almost two ounces of pure sugar, Plavinol’s active ingredient kept their glucose levels within a healthy range.”
• “Plavinol’s active ingredient is shown to reduce excess sugar in the blood which is why so many users are seeing a reduction in the symptoms of Metabolic Syndrome.”

NAD also determined that the studies submitted by the advertiser on other ingredients in Plavinol – biotin, chromium picolinate, milk thistle, and cinnamon – were not sufficiently reliable to support the challenged claims.

With regard to the challenged safety claims, “A pill that lowers high blood pressure in 30-days has been used safely in China for 54 years. It is now available in the United States” and “non-addictive and side effect free,” NAD recommended that they be discontinued because the advertiser failed to submit any testing demonstrating that Plavinol, or the ingredients therein, are safe, non-addictive or that it has been used safely in China for 54 years.

Finally, NAD recommended that the advertiser discontinue the claims “U.S. doctors are now recommending new Plavinol because it lowers blood sugar, triggers weight loss, and restores cholesterol, blood pressure, and triglycerides levels to normal without side effects,” “Approved by doctors nationwide” and doctor testimonials including:

• “Many Plavinol users report a decrease in high blood sugar within days, followed by a reduction in high blood pressure and cholesterol within the first month,” said Dr. James Leaper, Chief Medical Researcher for Plavinol.”
• “Plavinol is an excellent choice for overweight people. The clinical trials in support of the pill show it causes weight loss over a 90-day period,” said Dr. Holly Lucille, who has appeared on award winning TV shows like The Doctors, and PBS’ Healing Quest.”

NAD noted that the advertiser failed to submit a survey of doctors demonstrating that a substantial percentage of them recommend Plavinol to their patients suffering from metabolic syndrome or any of the conditions associated with it, which is the required level of support for “doctor recommended” claims.  With regard to the doctor testimonials, the advertiser did not provide any evidence that either Dr. James Leaper or Dr. Holly Lucille assessed the reliability of any studies on Plavinol to reduce high blood sugar, high blood pressure and cholesterol and to aid in weight loss.

In its advertiser’s statement, Nexus Formulas stated that “it will comply with the decision made by NAD on the advertising of Plavinol dietary supplement.”